Aclaris Therapeutics 宣布，其研发的候选药物 Modzatinib（ATI-2138）已获得美国食品药品监督管理局（FDA）授予的快速通道资格。这一资格认定针对的是该药物用于治疗中重度扁平苔藓（Lichen Planus，简称 Lp）的适应症。
快速通道资格旨在加速针对严重疾病且未满足医疗需求的药物开发与审评流程。获得此资格后，Aclaris 有望更频繁地与 FDA 进行沟通，并可能获得优先审评及滚动提交申请等便利。
此举标志着 Modzatinib 在临床开发中迈出了关键一步。扁平苔藓是一种慢性、炎症性自身免疫性疾病，可累及皮肤、黏膜及指甲，中重度患者常面临剧烈瘙痒、疼痛及生活质量严重下降的困境。目前，针对该病的有效治疗手段十分有限。
Modzatinib 作为一种口服的、高选择性 ITK/JAK3 双重抑制剂，旨在通过调节 T 细胞信号通路来抑制炎症反应。Aclaris 公司正积极推进其临床试验，以验证该药物在扁平苔藓及其他潜在适应症中的安全性与疗效。
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